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One Step rapid test kit for detection of HIV 1&2 Ab - India CDSCO Medical Device Registration

One Step rapid test kit for detection of HIV 1&2 Ab is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_be8ca5924258df3e9cb0568ac5a53c36_de3501aacd99643e4d703e0a9b091488. This device is marketed under the brand name Standard Q HIV 1/2 Ab 4-line ,Ultra HIV 1/2 Ab 4-line. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is Sub Zonal Baddi.

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CDSCO Registered
Class Class D
One Step rapid test kit for detection of HIV 1&2 Ab
UID: MFG/MD/2018/000005_be8ca5924258df3e9cb0568ac5a53c36_de3501aacd99643e4d703e0a9b091488

Brand Name

Standard Q HIV 1/2 Ab 4-line ,Ultra HIV 1/2 Ab 4-line

Device Class

Class D

Approving Authority

Sub Zonal Baddi

Product Information

It is a rapid, qualitative immunoassay to detect circulating antibodies to all iso-types of HIV in human serum, plasma or whole blood. The test is for in vitro diagnostic use and is intended as an aid to early diagnosis of HIV infection. This is intended for professional use, only for an initial screening test

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DJ Fang

DJ Fang

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